How to Automate a FSMA-Ready Food Safety Plan

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Alicia Richard
6 years ago
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1 How to Automate a FSMA-Ready Food Safety Plan And how technology helps streamline and improve food safety & quality whether you ll be impacted by FSMA or not!

2 Introduction As part of the FDA s Food Safety Modernization Act (FSMA), food and beverage companies that have to comply with FSMA are quickly trying to discern what regulations apply to them. And more importantly, what measures they need to put into place to ensure compliance. A large part of this process is defining the gaps of current food safety plans relative to the new requirements. And then incorporating new food safety plan procedures into overall programs. As part of this process of preparing for FSMA, companies throughout the food supply chain are recognizing the value of leveraging technology in order to handle the influx of complexities and recordkeeping requirements. Technology that will help them more effectively fulfill the requirements and ensure compliance. Not only can the technology help keep track of and ensure completion of Prerequisite Programs (PRPs), Corrective/Preventive Actions (CAPAs), FSMA s in-depth documentation requirements and more the right technology can help create bottom-line Return on Investment (ROI) by creating operational efficiencies that improve overall food safety & quality assurance (FSQA) operations. This ebrief will cover insights on: How a comprehensive FSQA operating system works How this technology helps with the 6 key components of a FSMA Food Safety Plan

How a Comprehensive FSQA Operating System Works A FSQA operating system is a comprehensive, preventive-based management solution designed to help ensure food safety & quality program execution at all

3 How a Comprehensive FSQA Operating System Works A FSQA operating system is a comprehensive, preventive-based management solution designed to help ensure food safety & quality program execution at all points along a company s value or supply chain. With real-time data collection and analysis to specifications along with automatic alerts when deviations are detected a comprehensive FSQA operating system can help prevent non-compliant ingredients and materials from coming in, and non-conforming finished products from going out. Additionally, it helps ensure program workflow, processes and documentation while also creating a central repository of FSQA data for trending, assessments, reporting, and of course, audit readiness. In understanding how a comprehensive FSQA operating system works - to paraphrase one of SafetyChain s colleagues, Dan Bernkopf, a 35-year FSQA guy who worked for quite a few USDA, FDA and HACCP regulated companies, he often says, Food Safety & Quality Assurance is all about saying what you do, doing what you say, making sure it works and making sure it s all documented. And that s what a comprehensive FSQA Operating System does.

4 Say What You Do All of your regulatory and non-regulatory requirements and programs are set up and defined in the system. All of the components of the food safety plans and data sources, that are necessary to support your requirements, are also set up in the system and associated with your programs. [This includes all of your SOPs, PRPs, GMPs, for example, as well as when they need to be reviewed/revised, sanitation schedules, forms, data from equipment such as cooling or weight machinery, and more.] Do What You Say A workflow engine ensures that all tasks associated with your requirements/programs (#1) including food safety monitoring activities are completed according to your documented schedules. All tasks are associated with forms, such as, but not limited to, those for internal direct observation inspections, quality attributes, internal/external lab data collection, and vendor forms. All tasks are scheduled via an electronic task scheduler with auto-notifications when tasks are due a notification to a supplier when a GFSI audit certificate is due or to a line supervisor that the metal detectors must be calibrated, for example. And incomplete or omitted tasks generate escalated alerts. Ensure it Works A verification engine analyzes all program data collected such as safety assessments from mobile forms or test results from a lab in real-time to the requirements and specifications defined in the system. If results are out of spec, a non-conformance alert is issued and CAPA can be automatically generated and tracked to completion. Make Sure it s Documented Every record collected is time and date stamped with esignatures where required and accessed from a central repository of data as part of your permanent FSQA record. Every document, test result, CAPA from every location are all accessible with your security login from any laptop or computer. Anywhere. Anytime.

The 6 Key Components of a FSMA Food Safety Plan and How Technology Helps Now that we ve established a foundation of how a comprehensive FSQA operating system works, let s examine how this technology

1- Product and Facility Plan FSMA requires that impacted food and beverage companies have a written food safety plan for every product (or groups of similar products) and facility.

5 The 6 Key Components of a FSMA Food Safety Plan and How Technology Helps Now that we ve established a foundation of how a comprehensive FSQA operating system works, let s examine how this technology can be leveraged to help with the 6 key components of a FSMA Food Safety Plan - Product & Facility Plan; Risk Assessment; Preventive Controls; Monitor, Verify, Validate; CAPA & Reanalysis; Document. 1- Product and Facility Plan FSMA requires that impacted food and beverage companies have a written food safety plan for every product (or groups of similar products) and facility. This requirement could literally mean that thousands, even tens of thousands, depending on the size of your company, of PRPs, CCPs, specifications, and more not to mention the potentially overwhelming increases in people hours to track and ensure that the plans are being followed. A comprehensive FSQA operating system helps manage Food Safety Plans regardless of the number of products and/or facilities companies may have. Capabilities include the ability to: Define an unlimited number of specifications, Preventive Controls/PRPs, CCPs, Standard Operating Procedures (SOP), Good Agricultural Practices, supplier requirements (including documents associated with FSMA s Foreign Supplier Verification Program), and more o All of the definitions can also be electronically identified by product/product groups and facility Automatic task scheduling allows you to set times/due dates for all PRPs, SOPs, CCPs, etc. o Initial and escalating alerts can be defined to further facilitate completion All of the above are maintained, regardless of the number of facilities and/or locations, in a central repository of data with dashboard access for monitoring, trending, audits, and a comprehensive look at your entire operation not only helping keep food safe but also helping with continuous improvement and finding ways to contain costs 2- Risk Assessment For your safety plan to be FSMA compliant, you must assess all risks that are reasonably likely to occur. Traditionally this has been a daunting task because the information required for such assessment was typically in many different formats and locations requiring many, many hours of manual entry for analysis. With a comprehensive FSQA operating system: All FSQA test results, inbound COAs, CAPA data, and more are accessible from a central repository of complete and accurate data This data then lends itself to in-depth analysis and trending in order to assess risks

3- Preventive Controls Once risks are assessed, the Food Safety Plan must contain Preventive Controls designed to do all that is possible to prevent potential risks that are likely to occur from

6 3- Preventive Controls Once risks are assessed, the Food Safety Plan must contain Preventive Controls designed to do all that is possible to prevent potential risks that are likely to occur from occurring. In addition to HACCP CCPs, Preventive Controls also cover plans for things like process controls, allergen controls, sanitation controls, training and recall plans. A comprehensive FSQA operating system helps you manage Preventive Controls with the ability to: Set up all Preventive Controls with defined schedules and notifications Have inbound COA information and/or data from internal FSQA tests analyzed against specifications in real-time Generate real-time alerts when a control isn t completed or FSQA test results deviate from specs 4- Monitor, Verify and Validate A FSMA Food Safety Plan calls for continuous monitoring, verification and validation of Preventive Controls after all, the idea is to prevent food safety outbreaks versus responding after the fact. In essence, monitoring, verifying and validating means saying what you re going to do, making sure you re doing it, and making sure that it works. A comprehensive FSQA operating system supports these efforts with the ability to: Again, define all PRPs, CCPs, etc., in the system so that you have the components of the plan documented and ensure that they are being completed when due via notifications from automated task scheduling capabilities Electronically gather all related data and information for real-time assessment against specifications o Data can include information and test results from suppliers, internal and 3 rd party labs, equipment, and even during transportation from, for example, temperature probes that communicate real-time data to the FSQA Operating System o In many cases, data can also be captured remotely on smart mobile devices preharvest assessment information, for example, during pre-harvest inspections Validation is achieved via real-time analysis against specifications and Food Safety Plan parameters, as well as real-time alerts on deviations, deficiencies and omissions

7 5- CAPA and Reanalysis FSMA Food Safety Plans require that when Preventive Controls fail, Corrective and Preventive actions be put in place. And that plans and controls must be reassessed periodically, to ascertain if there are areas for improvement, and also when there s a food safety incident caused by a failure in Preventive Controls. A comprehensive FSQA operating system helps you comply with these two requirements with: Real-time alerts that help ensure that CAPAs can be taken at the earliest point possible when deviations are detected o Time/date stamped CAPA documentation, including, when required or desired, before/after digital photos Upstream/downstream/internal visibility for root cause analysis and tracing how/when a safety deviation occurred A comprehensive database of all PRPs, CCPs and FSQA data for reassessment and continuous improvement 6- Document With FSMA, it is often said that if it isn t documented, you might as well not have done it. Everything must be documented the programs in the Food Safety Plan, proof of completion and validation, all test results and supplier documents, CAPAs, and more. A comprehensive FSQA operating system facilitates comprehensive documentation with: A centralized repository of all plan elements, test results, proof of PRP/CCP/SOP/GMP/GAP completion, CAPAs, and more helping you respond to audits and FDA/customer inquiries on demand; all data has unalterable time/date stamps for greater FSQA efficacy Additionally, now that you have a centralized repository of all your program data, you can trend and benchmark to help identify areas of improvement and achieve bottom line ROI o Supplier score carding o Adjustments to specifications for greater yield and product performance o Prevention of rework o The ability to help prevent withdrawals, rejections and recalls Reduction of errors and costs associated with manual data entry

Conclusion: How to Automate A FSMA Ready Safety Plan With the final FSMA rules now in place, and the first deadline for being compliant is fast approaching, understanding the gaps of your current

8 Conclusion: How to Automate A FSMA Ready Safety Plan With the final FSMA rules now in place, and the first deadline for being compliant is fast approaching, understanding the gaps of your current food safety plan- relative to the FSMA rules that apply to your companyis the critical first step. Then comes the harder part, ensuring that you re in compliance and audit-ready. And that s where technology can be leveraged to provide new operational efficiencies that deliver bottomline results. Results that ensure compliance and help you more effectively achieve the overarching goal of delivering a safe, quality product. SafetyChain Provides the Industry s Leading FSQA Technology Solution SafetyChain is the industry s only comprehensive platform designed to help ensure food safety & quality at all points along a company s supply chain upstream, downstream and internally. The SafetyChain FSQA Operating System and best-in-breed mobile apps provides the visibility, tools and intelligent data needed to more effectively manage, and improve, food safety & quality. With SafetyChain you can: Catch and Manage issues at the earliest point possible Enforce regulatory, third-party, customer, and internal program compliance Eliminate manual processes and errors while increasing scalability Prevent withdrawals, rejections and recalls Be Ready for inquiries and audits on-demand 24/7 Protect market value and brand More Information/Resources: info@safetychain.com

WHITE PAPER. Food Safety, From Farm to Fork. A Best-Practice Approach to Implementing a Food Safety Management System

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